S.L. 437.108 Art. 7Personnel.

It shall be the duty of the manufacturer to ensure that:

(a) at each manufacturing site there are a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objectives;

(b) the duties of managerial and supervisory staff, including the qualified person(s), responsible for implementing and operating good manufacturing practice:

(i) are defined in job descriptions;

(ii) their hierarchical relationships are defined in an organisational chart;

(iii) the job descriptions and organisational chart mentioned in sub-rule (b)(i) and (ii) respectively are approved in accordance with the manufacturer’s internal procedures;

(c) the staff referred to in paragraph (b) shall be given sufficient authority to carry out their responsibilities correctly;

(d) personnel shall receive initial and continuing training including the theory and application of the concept of quality assurance and good manufacturing practice;

(e) hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes include procedures relating to health, hygiene and clothing of personnel.